A child in Pakhistan getitng his polio drops.

As Afghanistan’s fragile health system battles for survival, hard-earned gains of the past 20 years in the tenacious battle against polio are under threat. But on a hopeful note, the new Taliban regime has just launched its first national polio vaccine campaign – reversing years of opposition to the life-saving intervention. 

Afghanistan witnessed the lowest ever polio transmission in 2021 providing what WHO officials have described at a recent Executive Board meeting as an “unprecedented” opportunity to interrupt transmission of wild poliovirus and ultimately achieve eradication. 

Only four cases of wild poliovirus type 1 (WPV1) were reported in the country last year.  Previously,  dozens of such cases would typically emerge. Leading up to this, two nationwide campaigns undertaken last year before the Taliban takeover in August 2021.  The campaign reached eight million children, including 2.6 million who were vaccinated for the first time. This has raised hopes for an end game for the crippling virus.

Taliban launch first-ever polio campaign – as Afghan health minister visits Geneva

Dr Qalandar Ebad, Acting Afghan Minister of Health

After years of opposition to vaccination, the Taliban government have pledged to maintain the momentum. The new Afghan government recently launched its first national polio immunization campaign for 2022, targeting 9.9 million children aged 0 – 59 months. However, the campaign is taking place against the continued spectre of hunger, humanitarian crisis and a “dire” health situation, according to WHO’s Director General Dr Tedros Adhanom Ghebreyesus.

Tedros met this week in Geneva with the Taliban’s acting Health Minister, Dr Qalandar Ebad, who arrived Sunday with a larger Taliban delegation, upon the invitation of the humanitarian group, Geneva Call, as part of an effort to unblock desperately needed humanitarian aid.

“Despite some improvements since then, the health situation in Afghanistan is still dire, and the acute humanitarian crisis is continuing to put lives at risk,” wrote Tedros in a tweet Wednesday, after Tuesday’s meeting.   Calling for continued dialogue with the Taliban, Tedros’ message also focused on the need to support Afghanistan’s COVID response and girl’s education. It was his  second meeting to date with the new Afghan health leader, following a visit by the WHO DG to Kabul in September 2021.

Taliban campaign reverses years of vaccine hesistancy

Desperately seeking international recognition and support, the Taliban-run Ministry of Public Health clearly now sees the uptake of polio vaccinations as an international and domestic win-win.  It has taken the lead in promoting polio vaccinations and convincing people to get their children vaccinated,  reversing years of vaccine hesitancy that characterised hardliners in the group.

In a televised interview this week, Ebad, a medical doctor by training, mentioned that immunization was among his ministry’s top priorities.

“Together with the international community, we would try our best to eradicate polio that is nearly diminished from Afghanistan. As a physician, I assure people that this is a disease that needs to be defeated on science-based international strategy, be it polio, measles or Covid-19 we would follow a global strategy,” he said. 

Afghanist & Pakistan are only countries remaining with wild poliovirus

Afghanistan and Pakistan are the only countries in the world that have been unable to stop endemic transmission of wild poliovirus, according to the World Health Organization (WHO). 

Pakistan has long blamed its polio cases on Afghan migrants and refugees, so Afghanistan’s battle is also one with high stakes for neighbouring countries who are concerned that any renewed outbreaks could spill over borders. 

While Afghanistan and Pakistan are still grappling with the wild poliovirus, the world is gearing up to roll out a new generation of polio vaccines to fight vaccine-derived polio cases that have been a problem in 27 countries in the African, Eastern Mediterranean, Europe and Western Pacific regions.

Finishing the eradication of wild polio in Afghanistan and Pakistan as well as advancing new vaccines to stamp out vaccine-derived polio cases in Africa, the Middle East and parts of Latin America and Asia,  were twin themes at the recent WHO Executive Board discussions on polio eradication – a health stream that is one of the largest in WHO’s budget. 

The discussions, which continued for hours, featured countries in Africa, Asia and the Eastern Mediterranean describing the challenges they face in rolling out a new generation oral polio vaccines to help wipe out vaccine-derived polio cases from older, less effective vaccine technologies – while remaining watchful of any risks from wild polio outbreaks. 

Ground Zero in the polio battle  

Last year, Africa was declared free of polio as a result of a determined 30-year effort. 

But in the fight against wild polio, Afghanistan remains ground zero in the battle. And the new immunization drive is taking place against the spectre of health worker protests that are stalling health service more generally. 

Evidently exhausted from relentless hours of duties, doctors and other frontline health workers have been on the street in a number of provinces protesting against the non-payment of salaries for months as the Taliban government struggles to manage budget flows amid the tough international sanctions imposed on it by the west.  

One protesting doctor based in the northern region of the country, Habibaullah Ahmadi, told the Health Policy Watch that he had not received his salary for 10 months now and was battling to survive. 

“We have decided to only continue work with few more days, but if we are still not paid our salaries, we will close the door of the hospitals because we all have families and we have a lot of problems, and we ask the international community to intervene and pay our due rights,” said Ahmadi.

Local authorities acknowledged the issue of non-payment of salaries, but blame the freeze on Afghan state reserves worth around $9 billion in the US for it. 

Recently,  doctors returned to work when the regional health head, Zaman Azami, assured the protesting health workers that their problems would be resolved ‘soon’.

The northern region of Afghanistan was the site of some of the deadliest clashes between the Taliban and the former government forces backed by  NATO, which resulted in disruption to the immunization drives last year and the emergence of most y of the new wild polio cases.

Although fighting has mainly ceased with the rise to power of the Taliban, the economic hardship that has followed has had an impact on the vaccination drives.

Meanwhile, the hardline Islamic State’s Khorasan (IS-K) chapter that recently claimed multiple deadly attacks in Afghanistan, continues to oppose the vaccination.

In the eastern provinces of Afghanistan marred by IS-K terrorism, at least four members of the polio vaccination team were gunned down and three others wounded last June. Back in March, three more members of polio vaccination team, all female, were shot dead by unknown assailants in the same area. 

Vaccine scepticism and attacks on vaccination teams

Children in Pakistan show proof of vaccination against polio.

Researcher and author, Ziaur Rehman, who has worked on polio campaigns for years, told Health Policy Watch that although the Taliban’s public stance on vaccinations has evidently changed, the mindset they nurtured against vaccinations during the past 20 years of insurgency will take years to address.

“If you remember it was broadly reported that the American CIA had used a Pakistani doctor, Shakil Afridi, to set up a fake polio vaccination campaign as a cover for the search for Al Qaeda chief Osama bin Laden in Pakistan. Ever since then, health authorities in Afghanistan and Pakistan have been struggling to win public confidence on the immunization,” Rehman said. 

A bunch of the Taliban splinter groups, particularly in the border regions between Afghanistan and Pakistan, continue to issue death threats to all those involved in the immunization campaigns despite the rise to power of the group in Kabul.

Echoing these concerns, senior Afghan paediatrician and former deputy director health, Dr Kabeer Ahmad told Health Policy Watch that scepticism towards polio and other vaccines still remain high, particularly in the rural communities. 

“If you go to the remote villages there are many people who still have serious doubts about the vaccine. It is in these communities, which also frequently travel between Afghanistan and Pakistan, that you see the virus transmitting.”

It is worth noticing that the WHO had said in a statement that Afridi was never part of any polio vaccination program in Pakistan – genuine or fake – and that baseless reports linking him to anti-polio efforts had damaged the ongoing vaccination campaign.

Remarkable progress

At the WHO Executive Board last month, WHO officials praised the “remarkable progress” in the fight against the virus in Afghanistan, and it was labelled as the “best opportunity” to end polio for the entire world. 

“To reach the final goal (of polio eradication). We need more of what we saw in 2021, the government leadership at all levels, and embedded access to children, informed and engaged communities and the highest quality of operations. And we need all of this to be sustained until transmission (of the virus) is interrupted, and the number of paralyzed children is at zero and kept,” said  Dr Ahmed Salim Saif Al Mandhari, WHO Regional Director for the Eastern Mediterranean Region, which includes Afghanistan and Pakistan.

The WHO has an estimated budget of $4.2 billion set aside for the five-year Global Polio Eradication Initiative 2019-2023 in partnership with UNICEF. The second component, starting in 2022, is the one-time cost of $121 million to have oral polio vaccine stockpiles (OPV) in place for use post-certification. Together, it brings the overall cost to achieve and sustain polio eradication to $5.1 billion

It was also underlined at the meeting that the world must not overlook the challenges that remain on this front such as the outbreaks of vaccine-derived polio viruses. 

Taliban seek international financial support

“I urge the member states to make domestic funding available to respond when needed, so that National Public Health capacities respond to outbreaks, as well as the COVID 19 pandemic, and are robust and can be integrated into broader public health services across steadily,” said Dr Al Mandhari, who also visited Kabul and met the Taliban leadership along with Tedros in September.

At the EB, many members state expressed commitment and support for the WHO’s immunization drive. It was stated that the financial support from the Global Polio Eradication Initiative will continue until the end of 2023 for the 10 countries at higher risk for polio, including Afghanistan while the 37 low-risk polio countries are being funded through the WHO based budget. 

After the assurance of funds by the international community, Ebad said that the immunization programs would cover the entire country rather than the 30-40% previous target.

The novel oral polio vaccine for type two, which received WHO’s first-ever emergency use listing in November 2020, has been introduced and delivered at scale in 12 countries using almost 200 million doses aimed at eradicating vaccine-derived polio transmission. 

The supply chain has since been strengthened with 640 million doses planned for delivery during 2022, according to the WHO. Still, at the Executive Board meeting of the WHO last month, the global health body’s chief, Tedros Adhanom Ghebreyesus warned against lowering guard against the crippling virus. 

“When there is success, we tend to lower our guard. So what I say is we need to be more aggressive, and we shouldn’t lower our guard. That’s what I say but eradicating polio is within reach,” said Tedros.

Image Credits: UNICEF Pakistan, Ministry of Public Health, Afghanistan.

Inside Afrigen’s R&D facility in Cape Town, South Africa – where scientists think they have copied Moderna’s COVID-19 mRNA vaccine recipe.

CAPE TOWN – The COVID-19 mRNA candidate vaccine, developed in two months flat by South African scientists based on Moderna’s “recipe”, might be too late for this pandemic, officials leading the project told Health Policy Watch, on the eve of a high-level WHO visit to the Afrigen Biologics & Vaccines facility where the vaccine formula was recently replicated.  

Still, the new WHO co-sponsored mRNA vaccine technology transfer hub based in South Africa aims to fill a longer-term mission, asserts Martin Friede, the WHO coordinator of the initiative in Geneva, in an interview with Health Policy Watch.  And that is to act as a “training hub” building out capacity for manufacturing cutting-edge mRNA vaccines in other low- and middle-income countries. 

And in the absence of a high-level commitment to support the mRNA hub from Moderna or Pfizer – other pharma partners with vaccine expertise have come forward, Friede said.

“I’m pleased to say that a few biotech companies have said we are prepared to share with you some of our knowledge about how to scale up,” said Friede, declining to name who those partners might be.

He and other officials spoke to Health Policy Watch on the eve of a planned visit here Friday and Saturday by WHO Director General Tedros Adhanom Ghebreyesus to Afrigen and other South African institutions collaborating in the new hub initiative. The visit by Tedros, accompanied by Belgium’s Minister of Development Cooperation, will likely bring more news of the expanding partnership around the hub.

Along with Afrigen, Tedros will also visit the Biomedical Research Institute, based at Stellenbosch University’s Tygerburg Medical Campus, and Biovac, among other collaborators in the new hub. While Afrigen is the R&D faciilty that is developing the vaccine, Biovac would provide for its manufacture, accoring to the WHO plan.

Meanwhile, at Afrigen, while the development of the new mRNA vaccine formula is an R&D breakthrough, the way forward to actual manufacturer remains littered with questions.

If the recipe can be demonstrated to be biologically equivalent to the Moderna vaccine, then the company might be able to bring it to market by next year, company CEO Professor Petro Terblanche, told Health Policy Watch. But without Moderna’s direct cooperation, the formula could take another three years to get through regulatory hoops, she admitted. 

“Our aim was to replicate the Moderna vaccine and that’s what we hope we have done. If there is equivalence, we might be able to fast-track clinical development. If there are variances then we will have to go for longer-term clinical trials,” Terblanche said.

She predicts that the company will only know which way the vaccine is headed in August, when it has made and tested good manufacturing practice-compliant (GMP) batches.

Vaccine’s development used ‘forward integration’ strategy

While Afrigen is doing the R&D, Biovac would be the first spoke of manufacturing for Africa’s own mRNA vaccines

In June 2021, a South African consortium including Afrigen, Biovac and the South African Medical Research Council (SAMRC) was chosen by the World Health Organization (WHO) to host a new international centre of excellence and training – now known as the mRNA vaccine technology “hub”.  They were tasked with making an mRNA vaccine, then sharing its know-how with companies and countries globally that lack this technology.  A parallel initiative, announced in September 2021, is also ongoing in Brazil’s Oswaldo Cruz Foundation and in Argentina’s Sinergium Biotech.

When the South African hub was first launched, the WHO appealed to pharmaceutical companies to share their know-how.  But Moderna and Pfizer-BioNTech did not respond. So Afrigen’s scientists had to take what was available in open published sources and try to figure it out for themselves (selecting Moderna over Pfizer simply because the company said that it wouldn’t enforce its patent during the pandemic).

“This is not reverse engineering, which implies that we’ve taken the actual vaccine, analysed that and worked backwards to meet the qualities and the composition of what we have analysed,” said Terblanche.

Instead, Afrigen’s scientists used a process of “forward integration”, Terblanche explains. They based their vacccine on the actual sequence for Moderna’s Vaccine 1273, which was discovered by Stanford University and is in the public domain.

From that, “we made the plasmid using our own scientific knowledge base, our own instruments, and our own process mapping;  we made the pDNA, we linearized and purified RNA and we encapsulated it”, she explains.

But while the sequence and the raw materials are the same, the precise vaccine formula still might be different – simply because “we don’t know the ratios because we don’t have the Moderna tech transfer”.

“So we have not pressed the button to make a copy of the Moderna vaccine. We are innovating from a sequence,” Terblanche stresses.

Still hopes that other major pharma firm – may join initiative

Terblanche remains hopeful another experienced pharma firm, will assist with scale-up as “there are always challenges when you scale it up so from the laboratory to big scale, making the vaccines”.

Afrigen needs help with issues such as some of the standard operating procedures, including the formula ratios of the lipid nanoparticles that encapsulate the mRNA; mixing conditions and encapsulating conditions, she says.

“We’ll have to experiment until we get it right or we can get assistance from Moderna or one of the other companies that have got it right to fast-track us,” she says. 

But so far, none of the big pharma firms with approved vaccines have come forward to offer such assistance.

Friede, who has been reaching out to the pharma industry from his seat in Geneva, says that announcement of a pharma partner is pending.

“And at last, I’m pleased to say that a few biotech companies have said we are prepared to share with you some of our knowledge about how to scale up so that you don’t spend too much time,” said Friede.

While Friede said he was as yet unable to name the companies, Moderna and Pfizer are not among them, he confirmed.

“What would have been great is if one of the companies that’s got approved vaccine came along and said ‘we’ll share with you our technology. We’ll share with you our data.’ If that was done, the South Africans would have been able to get a vaccine approved in a space of about 12 to 18 months. Without them, they’re still going to manage to get a vaccine made and approved, but it’s going to take at least three years.”

May be too late for COVID – but not for other diseases

Martin Friede, the WHO official who is coordinating the mRNA hub.

Whatever the timeline may be, the senior WHO official who led the creation of the hub, sees it as a long-term investment to combat future pandemics and diseases endemic to Africa – and accepts that this vaccine candidate might be too late for the COVID-19 pandemic.

“We don’t really know how this pandemic is going to pan out,” acknowledges Friede, himself an ex-pharma officer.  As the leader of an earlier WHO global initiative to develop regional hubs for the manufacture of influenza vaccines, which operated between 2006-2016 – he’s also got extensive experience in what it really takes to build vaccine manufacturing capacity. 

In any case, if the more virulent forms of COVID really fade away over the  few months, becoming another seasonal disease with predominantly mild outcomes in a population that has acquired immunity, then “none of the vaccines that are still in development will be of much use”, Friede told Health Policy Watch.

But if it drags on and countries need to give citizens booster shots, then the South African vaccine could still contribute in a practical way to squelching future rounds of SARS-CoV2, along with building regional capacity in mRNA vaccine manufacturing. 

Primary objective of hub is capacity building for future mRNA vaccines  

Inside Biovac – which is to be the first manufacturing spoke for the mRNA products produced by the South African Hub.

A primary objective of the mRNA hub is not only to build capacity in South Africa, but to train young professionals from other low- and middle-income countries (LMIC) to acquire and use cutting-edge mRNA vaccine technology and production capacity.

This can allow countries in the global South to respond more rapidly and agilely not only to COVID but also future disease threats, for which mRNA vaccines may be highly relevant  – “and there will be future outbreaks”, Friede stresses.

“We need to build a pipeline of other vaccines, for example HIV vaccines, to follow on after COVID to ensure that the facilities that we build are sustainable,” he explained in a recent video.

Ensuring sustainability by diversifying mRNA applications for other diseases

The investment in vaccine research, development and production is massive – the price tag for five years of the hub’s operation is $100-million.

That’s another reason why diversification of mRNA applications to other diseases is critical – ensuring sustainability beyond the current pandemic.

“Sustainability is really around developing a pipeline of vaccine candidates that are not necessarily for COVID, but for diseases of LMICs, particularly in Africa,” says Professor Richard Gordon, Director of International Partnerships at the South African Medical Research Council (SAMRC), another member of the hub consortium.

“The SAMRC’s role is to put together a consortium of researchers to be developing vaccine candidates for life after COVID,” says Gordon.

“We are fundraising, making grants and ensuring a continuum of vaccine candidates for other diseases for when COVID is a thing of the past. We’re going to need to work on HIV vaccines, TB vaccines, HPV, Chikungunya, and Africa Rift Nile fever,” adds Gordon.

But Gordon warns that while many people have romantic ideas about mRNA vaccines, diseases such as TB and HIV still aren’t going to be easy vaccine targets- . In the coming months, the SAMRC will assemble a scientific advisory group to prioritise the diseases most likely to be quelched by mRNA vaccines, he adds.

Staffing requirements another huge challenge

But Gordon admits that the part of the hub that keeps him awake at night is how to ensure that there are enough skilled people to scale up vaccine production – approximately 1000 people are going to be needed to staff the various vaccine initiatives in the country in the next few years.

“There are a number of initiatives on the way around capacity development and the MRC is really trying to be involved in many of them,” he said.  He cited the new WHO Academy, the Pan-African Vaccine Manufacturing group, and a soon-to-be-launched SAMRC scholarship programme being financed by billionaire Patrick Soon-Shiong.

Needs range from PhD graduates to new graduates in life sciences able to move into private tech companies. The new WHO Academy in Berlin is expected to help with training.

Terblanche says Afrigen will be working with the SAMRC to look at other vaccine candidates – adding malaria, Lassa fever, ebola and Schistosomiasis (bilharzia) to the list os possibilities.

“This facility was not designed for COVID-19 only. What we have built is a facility that has the ability to produce vaccines end-to-end from sequence right through to the final fill- finished product and to be multi-purpose and multi-product,” she stresses.

Hub set up in reaction to vaccine hoarding

WHO Chief Scientist Soumya Swaminathan

Said WHO Chief Scientist Dr Soumya Swaminathan, WHO decided to set up an mRNA hub in the face of vaccine hoarding by wealthy countries as well as export bans.

India’s decision to ban exports of its locally-produced version of the Astra Zeneca vaccine, Covishield, during the spring 2021 Delta wave was devastating for the global COVAX vaccine facility – which abruptly lost its main supplier, the Serum Institute of India, that was contracted to supply hundreds of millions of vaccine doses destined to Africa and other low-income countries.    

“It became very obvious that the countries that were suffering the most were those that were dependent entirely on imports,” says Swaminathan, adding that the WHO decided to establish a “multilateral mechanism for technology transfer”.

“The concept here is that it is a global hub that shares technology with anybody who wants  to receive it, focusing on LMIC countries and those which do not have adequate capacity,” says Swaminathan, adding that mRNA was chosen because it “has immense potential” for other diseases not just COVID-19.

The Medicines Patent Pool (MPP) is supporting the hub with licensing and fundraising, says executive director Charles Gore. France has already made a substantial donation to the hub.

“We had hoped that some of the originators of the current vaccines would come to us and agree to licence their technology to us that’s not happened,” said Gore, echoing the disappointment of Terblanche and Friede.

“But there may be licencing around second-generation technologies that we would like to incorporate,” adds Gore, who stresses that the mRNA hubs intend to strictly abide by existing patent rules.

Eventually, the WHO intends to have at least one mRNA vaccine training and production hub in each of its six regions. Along with the identified sites in Argentina and Brazil for the Americas,  other regions are expected to make announcements soon.

-Elaine Ruth Fletcher contributed to this story

Image Credits: Afrigen .

Healthcare workers in Nigeria have struggled to maintain routine childhood vaccination services during the COVID-19 pandemic.

Two years after the COVID-19 pandemic began, over ninety percent of countries continue to face ongoing disruptions to their health systems, according to a survey published Monday evening by the World Health Organization.

The WHO Global Pulse Survey, the third of its kind since the start of the COVID-19 crisis, analysed responses from 129 countries, territories and areas on the continuity of essential health services in the latter part of 2021.  The aim, WHO said, is to gain insights into the impact of the pandemic on these services and related changes that countries could be facing. 

At the end of the year, disruptions were occuring across practically every sector of health services – and at roughly the same rates as the first quarter of 2021, when vaccines were not yet widely available, found the survey, which covered both high, middle and lower income countries.

“Findings from this latest survey, conducted at the end of 2021, suggest that health systems in all regions and in countries of all income levels continue to be severely impacted, with little to no improvement since early 2021, when the previous survey was conducted,” stated a WHO press statement.

Strikingly, health workforce issues were found to be the biggest barrier to scaling up access to COVID-19 testing, treatment and vaccination. WHO said this is likely a result of staff exhaustion, workforce infections, and health workers leaving their jobs due to the stress of the pandemic.

More than a third (35%) of countries reported health workforce challenges more broadly beyond the bottlenecks in COVID-related healthcare services.

Disruptions across all major areas of healthcare services

In terms of other challenges, countries reported disruptions across all major health areas: sexual, reproductive, maternal, newborn, child and adolescent health, immunization, nutrition, cancer care, mental, neurological and substance use disorders, HIV, hepatitis, TB, malaria, neglected tropical diseases and care for older people. 

Moreover, at the same time that countries were scaling up their administration of COVID-19 vaccines, they reported increased disruptions in routine immunization services.

More than half of the countries responding to the survey said that many people are still unable to access care at the primary care and community care levels.

Elective surgeries were also disrupted in 59% of countries, which WHO said could have accumulating and long-term impact on personal health and well-being. 

Nearly one-third (32%) reported challenges accessing emergency room services.

Some 66 core health services across multiple delivery platforms and health areas were included in the survey.

Plans for recovery

At the same time, countries have tried to further beef up their responses to adapt and rebound from the continuing crisis, including with the provision of more home care and telemedicine; stepped up healthworker recruitment and training; procurement of “surge commodities” and more public financial support for the delivery of certain services, such as COVID testing or vaccination, to ensure wider uptake.

One-half of countries surveyed have developed a health service recovery plan to prepare for future health emergencies, and 70% of countries having allocated additional government funding to health workforce strengthening; access to medicines and other health products; digital health; facility infrastructure; and public engagement and communications.

As the survey responses were gathered up to November 2021, the data does not reflect the complex impacts on health services of the Omicron wave – which hit in late November.  That wave has infected unprecedented numbers of people in most countries around the world, including large numbers of healthcare workers.  At the same time, hospitalization rates have been proportionately lower than past COVID waves.  That allowed some countries to refocus efforts on other emergency and routine hospital procedures – although hospital capacity in other countries has been strained by surges in moderately and seriously ill COVID patients.   

The full report can be found here.

Image Credits: Twitter: @WHOAFRO.

Mexico City officials have been dishing out the animal worm treatment, ivermectin, to citizens with COVID-19 – and published a paper in which they apparently attempted to manufacture evidence that the treatment could reduce COVID-19 hospitalisation to justify their actions.

The paper was removed from the social science platform, SocArXiv, last week for trying to provide justification for “a government program that unethically dispenses (or did dispense) unproven medication apparently without proper consent or appropriate ethical protections according to the standards of human subjects research”, said the platform’s steering committee.

Until 4 January, the Mexican Institute of Social Security (IMSS) had included ivermectin as part of free COVID-19 care kits given to citizens who tested positive for COVID-19 – spending over $1,4million on the treatment, according to Animal Politico.

Ivermectin is mainly used to treat parasitic worms in animals, and is only approved for human use to treat certain parasitic worm infections, head lice and skin conditions like rosacea. 

Merck, which makes ivermectin, has warned that there is no scientific basis to use its medicine to treat COVID-19, while the World Health Organization (WHO) and other regulatory bodies have also stated that there is no evidence that the treatment has an effect on the coronavirus and could be harmful in large doses.

Ivermectin has been promoted as a COVID-19 treatment by conspiracy theorists and anti-vaxxers who claim that “big pharma” has tried to prevent recognition for the medicine as it would undermine their vaccine profits.

Between December 2020 and December 2021, the IMSS dished out 465,345 kits containing ivermectin to people with COVID-19 in Mexico City, the department told Reuters.

Mexico City Secretary of Health Oliva López was one of the paper’s authors.

‘Misleading and false’ paper removed

The row deepened last week after a paper authored by officials from the Mexican Social Security Institute and the Mexico City Ministry of Health – purporting to provide evidence that ivermectin can reduce hospitalisation – was removed from SocArXiv. 

On 4 February, SocArXiv director Philip N Cohen announced the withdrawal of the paper from his platform, which allows social scientists to share papers that have not been peer-reviewed.

Previously, the ​​steering committee of SocArXiv had said that “the article is of very poor quality or deliberately false and misleading”, but said that they had never removed an article and had no policy to do so.

However, they took action after an appeal by University of California-San Diego sociology professor Juan Pablo Pardo-Guerra, who described the paper as “deeply problematic and unethical” – along with the fact that the paper was proving to be hugely popular with readers and had been downloaded over 11,000 times.

According to Pardo-Guerra, the authors – including Mexico City’s Secretary of Health, Oliva Lopez  – had unethically recruited experimental subjects without their informed consent, and used dubious and unscientific methods. 

Generating false ‘evidence’

University of California-San Diego sociology professor Juan Pablo Pardo-Guerra

Pardo-Guerra wrote a blog about the incident last Friday, in which he accused the officials of “actively [generating] false evidence in order to justify their actions”. 

Pardo-Guerra contends that government officials decided to manufacture “evidence” of ivermectin’s efficacy in reducing COVID-19 hospitalisations to justify their expenditure in the face of mounting research proving that the medicine offered no benefit against COVID-19.

“In May 2021, the head of the Digital Agency for Public Innovation, José Merino, presented a small article, signed by him and other officials, as strong evidence supporting the actions of the capital government,” said Pardo-Guerra, who proceeded to pull apart the study.

As the ivermectin kits were not distributed in a randomized, controlled fashion, Merino and his coauthors used a “matching” technique to compare the hospitalization rates of those who received ivermectin with those who did not, simply by finding “similar people” based on sex age, symptoms, and comorbidities, said Pardo-Guerra.

“Without randomized controlled trials, it is simply impossible to say that the reported effects (decreased hospitalizations) are really products of the treatment or result from some other variable that was not considered,” he added.

“The kits also included aspirin and, given the intervention and analysis, it is impossible to know whether the reductions in hospitalizations were the effect of aspirin, ivermectin, or the graphic design of the kit.” 

Pardo-Guerra concluded: “Merino’s article, wrong in its design and analysis and immoral in its way of producing data, has been downloaded more than 11,000 times and is frequently cited on pages of dubious affiliation: from anti-vaccines, from private organizations that sell alternative treatments against covid-19 and other nefarious corners of the internet.”

In response, Merino has requested a hearing with the ​​steering committee of SocArXiv to address their concerns, claiming that they had not raised issues with the paper’s methodology. However, Cohen, the platform’s director, described his complaint as “noise” and added that if he was so confident of his methodology, Merino should send his paper to a peer-reviewed journal.

 

 

The African Union held its annual summit in Addis Ababa

The African Union has decided to elevate its African Centres for Disease Control and Prevention (Africa CDC) to the status of an autonomous public health agency for the continent – rather than operating simply as technical arm of the AU.

“Africa CDC will now be an autonomous health agency for the continent. Until now, Africa CDC was a specialized technical institution. It will now be elevated into a full public health agency for the continent, which will be more or less autonomous,” declared Dr John Nkengasong, Africa CDC’s director, on Sunday, the second day of the 35th AU summit that took place over the weekend in the Ethiopian capital of Addis Ababa.

The elevation of the Africa CDC – which will now report directly to Heads of State of AU Member Countries – signals the growing member state commitment to strengthening the continent’s response to current and future disease outbreaks, he added.

This development, Nkengasong said, is as a result of continent leaders’ renewed perception of disease as a security threat for the continent, in the wake of the COVID pandemic, among other disease trends. 

“They want to have full, timely access to anything that happens within the continent so that they can provide policy guidance. So I think that is extremely encouraging,” he added.

Summit leaders also pledged their support for the full-fledged establishment of the African Medicines Agency (AMA); aggressively combating malaria and female genital mutilation; and a 2022 AU “Year of Nutrition” – which would aim to get the continent back on track towards achieving Sustainable Development Goals for nutrition – as well as for resilient agriculture. 

Africa CDC Director John Nkengasong

Kenya calls on fellow heads of state to ‘sign up’ for AMA Treaty; Senegal is latest country to ratify 

The African Medicines Agency (AMA) treaty, which is now being backed by 30 African countries as previously reported by Health Policy Watch, was another major topic of discussion, with various calls by leaders and stakeholders for the agency to fully commence its operations soon. 

Senegal became the latest country to officially ratify the AMA treaty, while Kenya’s president hinted that the East African powerhouse Kenya could join soon.

Addressing his fellow heads-of-state, President Uhuru Kenyatta issued a strong call to African leaders to “sign up as soon as possible for this initiative” – saying that once operational, it will be critical in keeping people on the continent safer from disease threats.

“Several African countries have now signed the AMA treaty, enabling better access to newer, safer medicines.  I urge my fellow heads of state to sign up as soon as possible for this initiative,” Kenyatta declared.

At last month’s World Health Organization (WHO) executive board meeting, Kenya also expressed commitment to the AMA, in remarks made on behalf of the African bloc of WHO member states.

Kenya’s President Uhuru Kenyatta  speaking at the African Union’s 35th Summit

Senegal’s move means that so far 22 countries have ratified the treaty, while eight more have signed it, for a total of 30 countries in formal support.  Another 25 countries, including the economic and population powerhouses of Kenya, South Africa, Ethiopia and Nigeria have yet to sign or ratify the treaty instrument. See the countdown here:

Review of proposals for a host country for the new AMA institution are set to begin in April, with the first AMA Conference of State Parties (CoSP) set for May – where an assessment report will be presented for discussion on recommendations for a venue and next steps to establish the AMA.

Malaria goals lag

African Union media briefing on the Malaria Progress Report 2021, by Kenya’s President Uhuru Kenyatta and AU Health, Humanitarian & Social Affairs Commissioner Samate Cessouma Minata

On malaria, the Malaria Progress Report 2021 underlined that the African continent is not on track to eliminate malaria by 2030. Africa continues to account for the lion’s share – 98% – of global malaria deaths. 

Out of the total of 611,802 malaria deaths that occurred on the continent in 2020, the report noted that about 49,000 of the deaths were attributed to disruptions to malaria programmes and broader health services caused by the COVID-19 pandemic. 

Addressing journalists at the summit, Kenya’s President Kenyatta, who also chairs the African Leaders Malaria Alliance said far-reaching strategies need to be adopted to eliminate malaria.

“For us as a continent, we have attempted to fight malaria in the past but the disease is still a major threat to health and development in Africa,” Kenyatta said.

However, he added that African countries are making progress in implementing a four-point legacy agenda of digitization and scorecard accountability and action plans; a multi-sectoral advocacy, action and resource mobilization; regional coordination and access to life-saving commodities. 

“Happy to report that we have made good progress in implementing the four-point agenda. Countries continue to expand the use of digital tools to strengthen evidence-based accountability and the fight against malaria. All countries are implementing national scorecard tools on malaria, reproductive, maternal, newborn and adolescent and child health care, neglected tropical disease, nutrition and community scorecards,” he added.

See related Health Policy Watch story

Digital Scorecards Provide Citizens with Information on Neglected Tropical Diseases

Year of nutrition

At the summit, AU’s plan to declare 2022 as the “Year of Nutrition” was also finalized.  The plan notes that Covid-19 has greatly exposed the economic vulnerability of African countries, as well as the weaknesses of health and food systems. 

“With the COVID-19 pandemic, much of human capital gains in many economies over the past decade is at risk of being eroded. The price to pay for keeping the virus at bay has been, in many African countries, at the expense of gains made in reducing malnutrition,” the AU stated.

Specifically, it noted that the prevalence of wasting will also increase due to higher risks of acute food insecurity. 

The plan calls for urgent action to recoup and build upon pre-pandemic gains made against undernutrition and malnutrition, including reducing childhood wasting (low weight relative to height) and stunting (low height relative to age).

Stunting, a powerful indicator of undernutrition, still affects some 150.8 milllion children under the age of five, including 58.7 million African children.  Currently only seven AU member states out of 55 have stunting rates below 19%, while only 15 member states have child wasting prevalence below 5%. SDG Goal 2 – Zero Hunger – calls for reducing the prevalence of stunting by 40% by 2025, in comparison to 2012 levels. 

“Investing in human capital is now more important than ever through designing the needed interventions especially targeting the most vulnerable,” the plan asserts.

Researchers make the argument for increasing vitamin D supplementation in low- and middle-income countries, where vaccines and other methods of COVID prevention may be less available.

Vitamin D supplements
Vitamin D supplements

Maintaining adequate vitamin D levels could play a critical role in protecting against serious illness or death from COVID-19, according to new Israeli research.

The study, published last week in the journal PLOS ONE by researchers from the Azrieli Faculty of Medicine of Bar-Ilan University in Safed and the Galilee Medical Center in Nahariya, offers the most convincing evidence to date of the correlations between vitamin D deficiency and poor COVID-19 outcomes – making a case for supplementation, especially in low- and middle-income countries where vaccines and other prevention methods may be less available.

Vitamin D is a fat-soluble vitamin that has long been understood to affect immune response. However, as much as 70% of the adult population in Israel – and even larger percentages in some countries worldwide –  has insufficient or even deficient levels, according to Dr Amiel Dror, who led the study.

“We know that in countries from Africa to Georgia, and in much of the Middle East, people suffer from deficiency,” he said. “In some places, individuals avoid the sun because it is too hot; they stay inside their tents or huts or cover their bodies. Among some religious communities, like the ultra-Orthodox or traditional Islamic community in Israel, women are at higher risk for deficiency because of how they dress.”

Studies also show that low-income levels affect vitamin D levels due to poor diet or reduced exposure to sun, Dror explained. As such, even before COVID-19, most health authorities recommended supplementation. This new research shows that taking those supplements before contracting the virus could help patients avoid the worst effects of the disease.

People with sufficient vitamin D are 20% less likely to die from COVID-19

The Israeli study examined the records of 1,176 COVID-19-positive patients admitted to Galilee Medical Centre between April 2020 and February 2021 whose vitamin D levels had been evaluated between two weeks and two years prior to infection.

Patients with vitamin D deficiency (less than 20 nanograms per milliliter or ng/mL) were 14 times more likely to have severe or critical cases of COVID-19 than those with more than 40 ng/mL, the study found. Even more strikingly, mortality among patients with sufficient vitamin D levels was 2.3% compared to 25.6% in the vitamin D deficient group.

The study adjusted for age, gender, season (summer/winter) and chronic diseases, and found similar results across the board.

The study was conducted during Israel’s first two COVID waves, before vaccines were widely available, and before the recent Omicron outbreak. Dror said that coronavirus mutations should not negate vitamin D’s effectiveness.

Study checks vitamin D levels before infection

The study builds on a pre-print study that the team published in June on the health sharing server MedRxiv.

Those preliminary results found that people who were deficient in vitamin D were at least 20% more likely to die from COVID-19 than people who were not and that 26% of people who had a pre-infection level of vitamin D of 20 ng/mL died, compared with 3% of those who had higher levels of vitamin D.

Dr. Amiel Dror
Dr. Amiel Dror

However, that study received some pushback as it was unclear whether the vitamin D deficiency found in hospitalized COVID-19 patients was the result of the virus, making low vitamin D levels a symptom rather than a contributing factor to severe disease and death.

The newer study corrected that by analyzing vitamin D levels prior to infection.

“The infection itself alters the inflammatory status of our body and vitamin D is consumed, among other nutrients,” Dror said. As such, “we cannot conclude anything about vitamin D levels” in acute patients.

In October, soon after Dror’s first report, Israel’s Coronavirus National Information and Knowledge Center aggregated research studies that likewise showed a circumstantial relationship between one’s level of vitamin D and coronavirus, recommending supplementation. As a result, the country’s Health Ministry recommended increased vitamin D levels during the pandemic.

Different countries recommend different levels of vitamin D for their citizens, but on average the recommended amounts are as follows: Children under 1 should take 10 micrograms a day, kids and teens between the ages of 1 and 18 should take 15, and adults should consume 20 to 100 depending on their BMI.

Israel's recommended vitamin D levels by age group.
Israel’s recommended vitamin D levels by age group.

There have been interventional studies in which doctors tried to supply high doses of vitamin D to acute patients during hospitalization, but most of those studies did not show positive outcomes.

“The vitamin D we consume in drops, pills or in our food has to be activated in both our kidney and liver in order to be functional,” Dror explained. During COVID-19, liver function is generally impaired, which means that the patient will not necessarily be able to transform the consumed dose.

However, there was one study published last June that showed different results. In that study, scientists provided 447 patients at a Spanish hospital between March and May 2020 with calcifediol – a form of vitamin D that has already undergone liver activation – at admission. Of the patients, 20 required the intensive care unit compared to 82 out of 391 nontreated patients. Likewise, 21 out of the 447 patients treated with calcifediol at admission died compared to 62 patients out of 391 nontreated.

Not a replacement for vaccination

The positive results of the Israeli study have led some individuals “with a conspiracy theory mindset” to accuse the pharma industry of withholding information about the supplement in exchange for expensive vaccines or anti-viral treatments, Dror said.

But he stressed that vitamin D is not a replacement for inoculation and that while the Israeli study shows a strong correlation between vitamin D and severe disease and mortality, this is not the same thing as causation.

“In order to see if vitamin D truly abolishes COVID or makes the outcome so much better, we have to run a randomized, controlled study and give one group of patients vitamin D ahead of time and then measure the outcomes,” he explained.

“It is still unclear why certain individuals suffer severe consequences of COVID-19 infection while others don’t. Our finding adds a new dimension to solving this puzzle,” added study co-author Prof Michael Edelstein.

Dror recommended that countries consider giving out the supplement to get people used to taking it before the next wave, which he said is sure to come. The vitamin is cheap, easy to produce and simple to take, and unlikely to be met with hesitancy.

“We are not saying that vitamin D is the key to all bad coronavirus or that it is the ultimate solution,” Dror cautioned. “But we should take vitamin D to help our bones and our immune system anyway. If we can also benefit against COVID-19, it is a double win.”

Image Credits: Pixabay, Tomasz Solinski, Health Ministry.

Cancer statistics for the Maori people are very stark – 20% are more likely to develop cancer than non-Maori.

For the indigenous people of New Zealand, the Māori, cancer statistics are bleak, as they are 20% more likely to develop cancer, and twice as likely as non-Māori to die from it. But New Zealand-based Cancer Control Agency, Te Aho o Te Kahu, is trying to beat back against this inequity and close the gap in care for Māori people.

This story, and more, were among the many featured as part of World Cancer Day, a global initiative led by the Union for International Cancer Control (UICC) on 4 February. The theme for this year – ‘Close the Care Gap’ – addresses a need to address inequities in cancer care globally.

This inequity has been even more pronounced in recent years, with the COVID-19 pandemic setting back treatment services and progress in many parts of the world. 

“We see [inequities] on a day to day basis, and they impact the chances of someone developing cancer in their lifetime, and also someone surviving cancer,” said UICC CEO Cary Adams.  

Featured speakers and experts from around the world – from New Zealand, Switzerland, Kuwait, the Philippines, and others, discussed ways to close the cancer care gap, including in ageing and indigenous populations, and told stories of cancer survivors.

Engagement with indigenous groups necessary to address cancer care inequities in New Zealand

Michelle Mako, Equity Director at Cancer Control Agency, New Zealand,

Engagement is key to addressing the inequities surrounding cancer care, said Michelle Mako, Equity Director of the Cancer Control Agency. 

While exposure to risk factors such as smoking, alcohol, poor nutrition, lack of physical activity, and more drives up cancer incidence in Māori people, lack of access and lower utilization of primary care has also impacted cancer prevention and treatment. 

“Like many other nations, we are also seeing late detection of cancers in emergency departments, and we’re also seeing higher cancer rates with lower survival,” said Mako. 

To understand the gaps in care and potential solutions, Mako and the Cancer Control Agency spoke to around 2800 Māori with lived experiences of cancer in their families, as well as providers in the community.

New Zealand is also going through a series of health reforms, one of which will incorporate a new agency for the Maori people – the Māori Health Authority, which will work with the NZ Ministry of Health and other local health agencies to ensure equitable access to care for the Maori. 

Looking forward, Mako hopes that equity is achieved with cancer care in New Zealand, especially with these initiatives and more.

“I’d like to think that equity stops being a vague promise to do better or a fancy job title. I really hope that delivery equity just becomes standard practice and part of normal cancer care in the future.” 

Translating cancer care to aging populations 

cancer
Colon cancer rehabilitation trials in the UK. Quality of care is important in cancer care for ageing populations.

With the number of people 60 years and older to double in the next twenty years, and with cancer cases already impacting 37% of the elderly – a number that will also undoubtedly rise in the next twenty years, it is crucial that cancer care also address the needs of ageing populations. 

“The cancer workforce is not always prepared to meet the complex needs of patients with cancer,” said Nicolo Battisti, President-Elect of the International Society of Geriatric Oncology. 

Currently, in some parts of the world, there are few geriatric oncology clinics that are able to provide comprehensive care to these patients. Older people with cancer also tend to be excluded more frequently from innovative clinical trials.

But Rania Azmi, President of the Kuwait-based Fadia Survive and Thrive Cancer Association, has created an initiative centered around nine pillars that focus on meaningful discussion about elderly patients with cancer and patient-centered care in order to bring light to this issue.

Rania Azmi, left and Nicolo Battisti, right

One of the pillars considers the issue of functional age as opposed to chronological age for cancer patients, which makes all the difference for treatment.

“It’s not just the number – 60 or 70 or 80 that defines who’s at risk for cancer. It’s organ function,” said Azmi. 

Elderly patients also experience different cognitive changes and pain when it comes to cancer, so all knowledge and cancer control, including prevention, early detection, diagnosis, treatment, and even palliative care and quality of life, must be translated into actions to address their needs. 

“It’s really beyond oncology. To achieve [quality of care in elderly cancer patients] we need to hear the patient’s voice and have inclusion of patient decision in treatment,” Azmi noted.

Providing financial and psychosocial support to child cancer patients in the Philippines

The Kythe Foundation of the Philippines works with families and children with chronic illnesses.

Children and younger populations also have difficulties in accessing quality care, especially in the Philippines, according to Philippines-based Kythe Foundation co-founder and Executive Director Maria Fatima Garcia-Lorenzo. 

The Kythe Foundation provides both psychosocial support and family support to children and families with chronic illness. 

‘Adopted’ patients are also given full financial support – medicines, transportation, money for clean water – so that they can have a greater chance of surviving cancer. 

To celebrate their 30th anniversary, the foundation hosted a webinar in conversation with older cancer survivors and younger survivors, where they found striking differences in accessing treatment. 

“Our younger survivors had to really strive and line up to get financial help [for care]. They were not even diagnosed right away and had to go from one hospital to another to get proper diagnosis,” said Garcia-Lorenzo.

Maria Fatima Garcia-Lorenzo, Kythe Foundation

One survivor, according to Garcia-Lorenzo, did not even initially know what cancer was, causing him great fear and preventing him from complying with treatment.

“You could see the disparities, the inequities of the health system – the haves and the have-nots. Everyone should have access to treatment, medicine, and information.”  

The Kythe Foundation is already pushing for more funding from the Philippine government, health departments, and insurance agencies to provide for the needs of cancer patients.

Image Credits: einalem, World Cancer Day , Queen's University/Flickr, PTVph/Twitter .

Africa CDC director John Nkengasong

Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC) has told Health Policy Watch that the continent is not in short supply of COVID-19 test kits. According to him, every African country that is in need of the test supplies can get it if they want.

An open letter dated 31 January that was written by concerned members of civil society, clinicians, advocates, and communities affected by COVID-19, to the World Health Organization (WHO) urged it to rapidly recommend self-testing for COVID-19.

While calling on the global health body to expedite the finalisation and release of a self-testing guideline for SARS-CoV-2 infection that includes a strong recommendation in favour of widespread access to self-testing, they noted that low- and middle-income countries (LMICs) represent nearly 85% of the global population but that only 40% of tests for COVID-19 have been used in LMICs. 

“As a result, the reported average daily testing rate of high-income countries is, per capita, nearly 10 times higher than that of middle-income countries and close to 100 times higher than that of low-income countries,” the letter stated.

In Africa, according to the experts, citing WHO AFRO region, said 85% of COVID-19 infections are going undetected. 

“This inequity in access to the diagnostic tools that trigger life-saving individual and public health measures is part of the same ‘medical apartheid’ that has plagued the rollout of COVID-19 vaccines,” the experts noted.

But on Thursday, Nkengasong noted that Africa has seen a remarkable change and improvement in access to testing. 

“We are here in the middle of the African Union (AU) Summit and we are characterizing it as a COVID-free summit, which means every day we conduct testing on all the delegates, and those are thousands of people that are tested. We have not run out of tests,” Nkengasong said.

He said if countries follow the guidelines that the Africa CDC has given them, they will be able to access testing. 

Prioritising testing at the country level

He argued that the major determining factor for closing the COVID-19 testing gap in Africa is at the country level — enjoining governments to prioritise testing as a major cornerstone of their pandemic response.

While the continent’s testing data fluctuates from one week to another, it does not suggest that the continent is in short supply of testing kits, he added, describing the trend as a reflection of the priorities of the governments concerned.

“Testing will continue to be key. We see the test numbers fluctuate. Some weeks you have a very high increase in testing and then the following week you see a decrease. But that doesn’t necessarily reflect a lack of tests. 

Instead, he said the trend could suggest that countries actually engaged in testing or they are doing selective tests — “which most of the cases is about people who have symptoms or people that are trying to travel, not really systematic testing going on”.

In May 2020, the WHO published criteria in which it described a positive rate of less than 5% as an indicator that the epidemic is under control in a country. While this data for several African countries is not available, available data showed positive rates on the African continent ranging from 0.64% in Rwanda to 37.4% in Tunisia.

WHA’s Special Session resolved on 1 December 2021 to negotiate a new global pandemic instrument.

Representatives from Brazil, Egypt, Japan, Netherlands, South Africa, and Thailand are to make up the World Health Organization (WHO) Intergovernmental Negotiating Body (INB) on a future pandemic instrument, according to Knowledge Ecology International. 

The countries each represent a different region of the WHO, namely Africa (South Africa),  the Americas, known as the Pan-American Health Organisation (Brazil), the South-East Asian Region (Thailand), Europe (Netherlands), the Eastern Mediterranean (Egypt) and the Western Pacific (Japan).

South Africa confirmed that it had been chosen to represent Africa at the INB at last week’s WHO executive board meeting, while the European Union announced that it would be represented by an official from the Netherlands.

Last year’s World Health Assembly (WHA) Special Session resolved to start intergovernmental negotiations “to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”.

According to the WHA resolution, the first INB meeting shall be held no later than 1 March to “elect two co-chairs, reflecting a balance of developed and developing countries, and four vice-chairs, one from each of the six WHO regions” as well as “define and agree on its working methods and timelines”.

The resolution also directs the INB to “first identify the substantive elements of the instrument and to then begin the development of a working draft to be presented, on the basis of progress achieved, for the consideration of the INB at its second meeting, to be held no later than 1 August 2022”.

The INB has until the 77th WHA next year to present a draft of the instrument, but needs to present a progress report to this year’s WHA.

 

african medicines agency
Ambassador Samate Cessouma Minata, AU Commissioner for Health, Humanitarian Affairs and Social Development (HHS)

Some 21 countries have now ratified the African Medicines Agency treaty – well beyond the 15 ratifications reached in November 2021, which allowed the AMA treaty instrument to formally take effect.

Egypt, Africa’s third most populous country, is the most recent state to have both ratified and deposited the treaty – marking a significant milestone in the efforts to get the continent’s bigger players on board.

Altogether, 19 African countries have both ratified and deposited the AMA treaty instrument to the AU secretariat, said Cessouma Minata Samate, African Union Commissioner for Health, Humanitarian Affairs and Social Development, at a press briefing on Thursday. She was speaking at a briefing on the margins of the 35th African Union Summit, which takes place this weekend.

Two more countries,  Morocco and Saharawi, have also ratified the treaty – but are yet to deposit it – rounding out the 21.

Another nine countries have signed the treaty, but are yet to ratify it – including Equatorial Guinea and Comoros, which signed over just the past week, said Samate.

All in all, that makes for a total of 30 countries that are formally on board with the treaty through signature, ratification, or both – while 25 still remain uncommitted.

The new agency is supposed to provide a streamlined regulatory authority that would improve quality medicines access, and combat substandard imports, backers say.

“The AMA will also guide the regulation of medicines, and facilitate access to quality medicines on the continent,” underlined Samate.  

Africa’s biggest economies still hold out

 

Despite that promise, the 25 countries that have not yet signed the treaty include most of Africa’s population and economic powerhouses — such as Nigeria, South Africa, Kenya and Ethiopia.

Responding to queries regarding the fence-sitters, Samate deferred, attributing the delays to  variations in respective countries’ signing and ratification procedures. 

“I do not want to answer why Ethiopia did not sign; I am not part of the government. But each country has its procedure. There are several procedures involved. There is a whole process for it to arrive at the Parliament which will ratify it, and it depends on each country,” she said. 

“Each country has its rules for signing and ratifying treaties,” she said.

She however added that since the treaty is new, sufficient time has to be given to Member States to sign and ratify it. Ultimately, however, all member states recognise it is in the best interest of citizens on the continent. 

“I am sure that all the countries are committed.” 

AMA will improve medicines regulation and access on the continent

State of play as of 2 February in the alignment of 30 AU member states around the AMA treaty. Another 25 states have yet to sign or ratify.

Samate noted that the AMA will be important in coordinating between the continent’s sub regional blocs, which have different economic alliances, also affecting trade and thereby medicines regulations.  

“The agency will coordinate the actors at the level of our subregional economic communities, and will work with AU Member States to enable us to have efficient health systems to treat our various populations.” 

“It’s important for us to have an agency for ourselves – to serve as a regulator for medicines issues on the continent,” she said. 

Others have emphasized that the AMA could help speed access to medicines – by conducting reviews and issuing recommendations on new treatments, which could take counties much longer to tackle individually.  And it could help bring down some medicines prices by facilitating regulatory harmonization – which permits more bulk imports.  

In addition, it is hoped that the agency can play a role in fighting substandard and fake medicines. Currently WHO’s African Region suffers from the highest rates of reports of fake and substandard medicines in the world, according to both the WHO and AU officials.  

 Timeline for setting up the new agency 

The next step in transforming the AMA from a treaty to an actual institution is to decide on a host country for the agency’s headquarters, Samate told journalists. 

This is not expected to be completed at the AU Summit – insofar as the criteria and process are yet to be announced. But she affirmed that the process would get underway “very shortly.”

“There will be a process to allow the member states to decide, very shortly, which African country will host the AMA,” she told journalists. 

Sources, however, told Health Policy Watch that the process of assessing countries vying to host the AMA may not really begin until April. 

However an initial meeting of the AMA Conference of State Parties (CoSP) is scheduled for May – where an assessment report will be presented for discussion on recommendations for AMA host country. 

Following that, the terms of reference for the AMA Director-General will then be considered by the CoSP – to pave the way for recruitment of an agency head. Lastly, the site for the proposed AMA headquarters is expected to be adopted by the AU Assembly to be held in July 2022.

Meeting ambitious goals

The AMA treaty document was first approved by the African Union in 2019. At a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda in December 2021, panellists described the AMA as critical to Africa achieving the set goal of producing 60% of vaccines on its own soil by 2040.

Ahead of the African Union Summit held over the past weekend, the African Medicines Agency Treaty Alliance (AMATA), an alliance that represents patients, academia, civil society, and industry set up to advocate for the ratification and implementation of the AMA, applauded the momentum reached so far.

They called for a set of key steps to be taken in order to operationalise the Agency, including setting up a secretariat and choosing its location, adequate human resource capacity to operationalise its mandate and a sustainable funding model to ensure short- and long-term stability.

AMATA also stressed the importance of recognizing patients as key partners in the development of the Agency – as part of a framework of engagement with non-state actors, including academia, research bodies, private sector and other civil society groups. 

They also appealed to all other African countries to ratify the AMA to “strengthen the continent’s capacity and preparedness to deal with future pandemics”, foster a spirit of cooperation to enable the development of medicines and vaccines, and safeguard the health of the continent and to protect citizens of Africa from fake m.

Image Credits: African Union .